Yahoo Finance Randomized Controlled Study Supports Vitalis Analgesic’s Oral Ketamine as a Potential Treatment of Acute Pain
Study published online in American Journal of Emergency Medicine (https://doi.org/10.1016/j.ajem.2022.05.026)
NEW YORK, June 29, 2022 (GLOBE NEWSWIRE) -- Vitalis Analgesics LLC, a specialty pharmaceutical company leveraging its innovative VTS platform to overcome the limitations of existing drugs, today announced the publication of a randomized, controlled trial (RCT) that supports the Company’s proprietary VTS aspirin/ketamine formulation (VTS-85) as a potential oral treatment for acute pain. The study was published online in American Journal of Emergency Medicine.
“The results of this study, along with a recently published pilot study, demonstrate the potential of VTS-85 to produce analgesia similar to studies using intravenous ketamine but lasting longer and with lower side effects,” said Joseph Habboushe, MD, MBA, inventor of the VTS platform.
VTS-85 is a proprietary formulation of aspirin and ketamine, which aims to unlock the potential of ketamine in an oral formulation. This could lead to synergistic analgesic activity and potentially reduced side effects, which currently prevent outpatient use of ketamine.
The study was a prospective, randomized open-label trial of patients presenting to the emergency department (ED) with severe acute musculoskeletal pain. Sixty patients were randomized 1:1 to treatment with aspirin and ketamine designed to be fully swallowed, or a proprietary ketamine arm. The primary outcome was the difference in pain scores at 60 minutes between the two groups. Secondary outcomes included adverse events (AEs) and the need for rescue analgesia. More details of the study design can be found here: NCT04860804.
Both arms resulted in peak and length of analgesia better than has been reported in the literature for oral ketamine for pain. There was a mean reduction in pain score at 60 mins of 2.1 points in the swallowed aspirin and ketamine arm, and 4.1 points in the proprietary ketamine-only arm, which simulates the ketamine in VTS-85. The pain reduction in the ketamine only arm was comparable to pain reduction with a combination of VTS-aspirin and a proprietary ketamine release profile reported in a similarly designed open-label pilot study (https://doi.org/10.1016/j.jemermed.2022.01.029 that incorporated all of the innovative steps of VTS-85 (NCT04702555).
“The results of this study and a pilot proof-of-concept study are very encouraging,” said Dr. Sergey Motov, principal investigator of both the RCT and pilot studies. “The proprietary release formulations resembling VTS-85 demonstrated surprisingly strong pain reduction given the known poor bioavailability of oral ketamine. Based on the data observed to date, we believe that VTS -85 has the potential to be a useful for a wide range of acute painful conditions including acute post-operative pain.”
Dr. Habboushe added, “Because of these results, we now anticipate initiating a clinical trial in acute post-operative pain in orthopedic patients.”
About Vitalis Analgesics LLC
Vitalis Analgesics was spun out of Vitalis Pharmaceuticals to help unlock ketamine’s enormous potential as an oral medication in pain, mood disorders, and more. Ketamine use has been limited by low bioavailability, short duration of action and serious adverse effects. An oral ketamine with favorable side effect and pharmacokinetic profiles may be a breakthrough, opening up life changing treatments for many patients. Since 2012, Vitalis Pharmaceuticals has aimed to leverage its proprietary VTS platform to overcome the limitations of existing drugs and enhance the patient experience across a variety of therapeutic areas. Our goal is to develop patient-centric therapies that improve disease treatment with fewer side effects, and that offer a higher quality of life. For additional information, please visit www.vitalisanalgesics.com.
Contact:
Burns McClellan for Vitalis Analgesics
Lee Roth (Investors) / Robert Flamm, Ph.D. (Media)
212-213-0006
lroth@burnsmc.com / rflamm@burnsmc.com
